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Immediate optimal endocrine adjuvant therapy versus standard chemotherapy followed by the same endocrine therapy in pre- or perimenopausal patients with early hormone receptor-positive breast cancer the PROMISE study.


- candidate number1560
- NTR NumberNTR357
- ISRCTNISRCTN23561723
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleImmediate optimal endocrine adjuvant therapy versus standard chemotherapy followed by the same endocrine therapy in pre- or perimenopausal patients with early hormone receptor-positive breast cancer the PROMISE study.
- Scientific TitleAn open label randomized (inter)national multicenter comparative trial of 5 years adjuvant endocrine therapy with a LHRH agonist plus an aromatase inhibitor (goserelin + anastrozole) versus 5 courses FE90C chemotherapy followed by the same endocrine therapy in pre or perimenopausal patients with hormone receptor-positive primary breast cancer (PRemenopausal Optimal Management IS Endocrine therapy).
- ACRONYMPROMISE, BOOG 2002-01
- hypothesisTo compare the efficacy and tolerability of immediate optimal endocrine adjuvant therapy versus standard chemotherapy (5 endocrine therapy in pre- and perimenopausal patients with ER and/or PR courses FE90C) followed by the same positive primary breast cancer.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria1.. Pre-/perimenopausal patients aged less than 60 years at entry of the trial. Patients must have had their last menstrual period less than 2 years before surgery of the primary tumor. In previously hysterectomised patients, women with both postmenopausal plasma FSH and estradiol concentrations will be excluded;
2. a. Any N+ subgroup (N1-3, N4-9, N10); b. Any high-risk N0 subgroup which meets one of the following criteria:
b1. Tumor size >= 3 cm;
b2 Tumor size 2-3 cm with grade II or III;
b3.Tumor size 1-2 cm with grade III;
b4. Patients < 35 years of age (with exception in case of tumors ≤ 1 cm, grade I);
3. ER or PgR receptor status positive as defined by local hospital criteria (as cut-off levels are adviced minimally >= 10% positively staining tumor cell by immunohistochemistry or >= 10 fmol/mg protein by ligand binding assay). ER-positive, PgR-negative patients are eligible;
4. Patients with either Her2/neu negative or positive tumors are eligible;
5. No previous systemic therapy for breast cancer;
6. Adequate hematological-, renal- and hepatic function (defined as PLT > 100x109/L, WBC > 3x 10 9/L, Creatinine< 1.5 UNL and SGOT (ASAT) or SGPT (ALAT) < 2.5 UNL);
7. Accessible for follow-up for the duration of the trial;
8.ECOG performance status 0 or1 (appendix II);
9. Written informed consent (according to ICH/GCP and local IRB guidelines).
- Exclusion criteriaThose patients who did not undergo intended curative primary treatment or who fulfilled one of the following criteria:
1. Inflammatory breast cancer;
2. Positive supraclavicular nodes;
3. Ulceration/infiltration of local skin metastasis;
4. Primary surgery was completed more than 12 weeks before starting the randomised treatment;
5. Both ER negative and PgR negative primary tumor;
6. Evidence of distant metastases (M1);
7. Patients who have received previous systemic endocrine and/or chemotherapeutic treatment for breast cancer;
8. Uncontrolled cardiac disease including unstable angina, CHF or arrhythmia requiring medical therapy or with a history of myocardial infarction within the past 3 months or any other serious concomitant disease;
9. Psychiatric disorders preventing proper informed consent;
10. Tumor with a size < 1cm and N0 and age > 35 years;
11. Tumor size 1-2 cm, N0 with grade I or II and age > 35 years;
12. Tumor size 2-3 cm, N0 with grade I and age > 35 years;
13. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin, unless agreed by the Steering Committee. Subjects with other malignancies must be disease-free for at least 5 years. Patients with a history of breast cancer should be excluded;
14. Other serious illnesses that may interfere with subject compliance, adequate informed consent or determination of causality of adverse events;
15. Patients who are using contraceptive pills or receiving any HRT for treatment of peri-/postmenopausal symptoms should stop taking these endocrine agents at least 4 weeks prior to randomization;
16. Pregnancy or breast feeding;
17. In case a germline BRCA1 or BRCA2 mutation is known in the family of the patient, it is adviced not to include such patient in the study because of the different management of these patients and the increased risks of contralateral breast cancer and ovarian cancer (it is not warranted to perform standardly a DNA-test within the context of this trial).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jul-2005
- planned closingdate31-dec-2011
- Target number of participants25
- Interventionsarm A: goserelin + anastrozole for 5 years (experimental arm)
B: 5 courses of FEC90 followed by goserelin + anastrozole for 5 years Goserelin is available as 4-weeks depot (Zoladex 3.6 mg) and as 3-month depot (Zoladex 10.8 mg). Zoladex 3.6 mg depot will be administered subcutaneously every 28 days.
The Zoladex 10.8 mg depot will be administered every 12 weeks. Anastrozole 1 mg/day FEC90 (standard dose, day 1, every 21 days):
- Cyclophosphamide 500 mg/m2 i.v. (push)
- Epidoxorubicine 90 mg/m2 i.v. (push)
- 5-Fluorouracil 500 mg/m2 i.v. (push)
- Primary outcomeRelapse-free survival (RFS).
- Secondary outcome1. Overall survival (OS), the incidence of contralateral breast cancer;
2. Safety and longterm tolerability of both treatment regimens.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.G.M. Klijn
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.G.M. Klijn
- Sponsor/Initiator Breast Cancer Study Group (BOOG)
- Funding
(Source(s) of Monetary or Material Support)
CKTO, AstraZeneca
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-sep-2005 - 6-mrt-2006


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